Cleared Traditional

Diode Laser Body Sculpture Systems

K231131 · Shanghai Bele Medical Technology Co.,Ltd · General & Plastic Surgery
Jun 2023
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K231131 is an FDA 510(k) clearance for the Diode Laser Body Sculpture Systems, a Laser For Disruption Of Adipocyte Cells For Aesthetic Use (Class II — Special Controls, product code PKT), submitted by Shanghai Bele Medical Technology Co.,Ltd (Shanghai, CN). The FDA issued a Cleared decision on June 22, 2023, 62 days after receiving the submission on April 21, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number K231131 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2023
Decision Date June 22, 2023
Days to Decision 62 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code PKT — Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.5400
Definition Laser Intended For The Disruption Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas.